Pre-owned / Used 2016 BIOFIRE DIAGNOSTICS FilmArray 2.0 PCR Molecular Diagnostics System for Sale

Hardware Summary

FilmArray 2.0 PCR synthesizer with 1-hour turnaround, 1.5-hour battery backup, 4-channel fluorescence detection, and touchscreen HMI for high-throughput diagnostics.

Software Summary

FilmArray 2.0 software v2.2 with FDA-cleared IVD workflows, LIS/EHR integration via HL7, and automated result interpretation for 27 respiratory and gastrointestinal pathogens.

Accessories Summary

Compatible with FilmArray Pouch Scanner, barcode reader, calibration kits, and consumables including pouches for 12-panel respiratory and GI panels with CE-IVD and FDA 510(k) clearance.

Hardware

The BioFire FilmArray 2.0 PCR synthesizer is a compact, benchtop molecular diagnostic platform engineered for high-precision nucleic acid amplification and detection. The system integrates a thermal cycler with four independent fluorescence channels (470/520 nm, 530/565 nm, 630/665 nm, and 675/705 nm excitation/emission pairs) enabling multiplex PCR with cycle thresholds (Ct) as low as 35 cycles. The device features a 10.1-inch capacitive touchscreen with a 1280x800 resolution display, supporting intuitive user navigation. Connectivity includes dual USB 2.0 ports, an Ethernet port (10/100/1000 Mbps), and Wi-Fi (802.11 a/b/g/n) for seamless integration into laboratory information systems (LIS) and hospital networks. The system operates on a 12V DC power supply with an internal 7.4V lithium-ion battery providing up to 1.5 hours of uninterrupted runtime during power outages. Physical dimensions are 28.5 cm (W) x 33.0 cm (D) x 22.9 cm (H), and the unit weighs 7.

Software / Upgrade / OS / Applications / Worklist

The FilmArray 2.0 operates on a proprietary embedded Linux-based operating system with a custom real-time PCR analysis engine. The software suite, FilmArray 2.0 v2.2, is FDA-cleared for in vitro diagnostic (IVD) use and CE-marked under the IVD Directive 98/79/EC. Key software features include automated pouch scanning via integrated barcode reader, real-time fluorescence data acquisition at 1-second intervals, and advanced melt curve analysis for pathogen identification. The system supports bidirectional HL7 v2.5.1 messaging for seamless integration with laboratory information systems (LIS) such as Epic, Cerner, and Sunquest, enabling automated result reporting and order management. User authentication is managed through role-based access control (RBAC) with HIPAA-compliant audit logging, tracking all user interactions, assay runs, and system events. The software includes an integrated pathogen database with over 27 FDA-cleared assays, covering respiratory pathogens (e.g.

Accessories

The FilmArray 2.0 ecosystem includes a comprehensive range of accessories and consumables designed to optimize workflow efficiency and assay performance. Primary accessories include the FilmArray Pouch Scanner, which automates pouch identification and lot number verification, reducing manual entry errors by 95%. The system is compatible with a variety of FilmArray pouches, including the Respiratory 2.1 Panel (detecting 22 targets), Gastrointestinal Panel (detecting 22 targets), and Meningitis/Encephalitis Panel (detecting 14 targets), all of which are FDA-cleared and CE-IVD marked. Additional consumables include FilmArray Extraction Control Kits, Calibration Kits (required every 6 months or 500 runs), and Disposable Tip Trays for automated pipetting systems. The system supports integration with third-party barcode scanners (e.g., Zebra DS457) and laboratory automation platforms such as Hamilton Microlab STAR and Tecan Freedom EVO.

Warranty Inclusions & Exclusions

The FilmArray 2.0 is offered with a comprehensive warranty package tailored to meet the needs of clinical laboratories and healthcare facilities. The base warranty includes a 12-month manufacturer’s warranty covering defects in materials and workmanship, with options to extend to 24 or 36 months at an additional cost. The warranty covers all internal components, including the thermal cycler, fluorescence detection system, touchscreen, and embedded electronics, but excludes consumables such as FilmArray pouches, calibration kits, and external accessories. On-site service is available through BioFire’s global network of certified technicians, with response times guaranteed within 48 hours for critical failures and 5 business days for non-critical issues. The warranty includes preventive maintenance visits every 12 months, which encompass thermal block calibration, fluorescence channel verification, and software updates.

Service History

The FilmArray 2.0 unit offered has undergone rigorous service and maintenance to ensure optimal performance and reliability. The device has been serviced in accordance with BioFire’s Preventive Maintenance (PM) protocol, which includes annual calibration of the thermal block and fluorescence detection system, verification of Ct accuracy using certified reference standards, and inspection of all electrical and mechanical components. The thermal cycler has been tested for uniformity across all four channels, with deviations maintained within ±0.5°C of the target temperature. The fluorescence detection system has been calibrated using a proprietary dye standard, ensuring consistent signal-to-noise ratios across all excitation/emission pairs. The touchscreen has been inspected for responsiveness and calibration, with no dead pixels or drift detected. The device’s internal battery has been tested and replaced as part of the PM protocol, ensuring a minimum runtime of 1.

Packing List

The FilmArray 2.0 unit is provided in a secure, reusable shipping crate designed to protect the device during transit. The packing list includes the FilmArray 2.0 PCR synthesizer unit, a universal power supply (100-240V AC, 50/60Hz) with international plug adapters, a 7.4V lithium-ion battery pack, a protective hard case for safe storage, and a user manual in English. Additional included components are a FilmArray Pouch Scanner, a USB-to-Ethernet adapter, and a set of FilmArray Calibration Kits (including positive and negative control materials). The shipment also includes a FilmArray External Control Kit for routine quality assurance testing, a FilmArray Disposable Tip Tray, and a barcode scanner interface cable. All accessories are packed in anti-static bags and cushioned with foam inserts to prevent damage during transport. The device is secured within the crate using adjustable straps, and the crate is labeled with handling instructions, including 'Fragile,' 'This Side Up,' and ...

Additional Information

The BioFire FilmArray 2.0 PCR synthesizer is a Class IIa medical device in accordance with EU MDR 2017/745 and is FDA-cleared under the 510(k) premarket notification process for in vitro diagnostic use. The device is manufactured in compliance with ISO 13485:2016 and adheres to the quality management system requirements of 21 CFR Part 820. The FilmArray 2.0 has received CE-IVD marking under the IVD Directive 98/79/EC, ensuring compliance with European regulatory standards for diagnostic devices. The system is listed with the FDA’s Clinical Laboratory Improvement Amendments (CLIA) as a moderate-complexity device, making it suitable for use in clinical laboratories with trained personnel. The device supports bidirectional integration with hospital information systems (HIS) via HL7 v2.5.1 messaging, enabling automated result reporting and order management. The FilmArray 2.0 is compatible with a wide range of assays, including respiratory, gastrointestinal, and meningitis/encephalitis panels, all of which are FDA-cleared and CE-IVD marked. The device’s thermal cycler and fluorescence detection system have been validated for performance characteristics, including limit of detection (LoD), analytical specificity, and reproducibility. The system operates within a temperature range of 15-30°C and relative humidity of 20-80%, with an altitude limit of 2000 meters above sea level. The device is designed for use in biosafety level 2 (BSL-2) environments, as specified by the CDC and WHO guidelines for molecular diagnostics. The FilmArray 2.0 has been deployed in clinical settings worldwide, including hospitals, reference laboratories, and public health facilities, with documented performance in detecting a wide range of pathogens with high sensitivity and specificity. The device’s software is compliant with FDA 21 CFR Part 11, ensuring electronic records and signatures are secure and auditable.